Assessment of Left-sided Cardiac Sparing Through the Use of 3-dimensional Surface Matching-based Deep Inspiration Breath Hold and Active Breathing Control

NCT03459898 | Completed

• 1 other identifier: 268-2017
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The standard treatment for breast cancer is surgery followed by adjuvant breast radiation therapy in most cases. For left sided breast cancers, the heart dose delivered by the radiation treatment is often of particular concern. In order to spare the heart, different strategies are currently available, including active breathing control (ABC) and voluntary deep in inspiration breath hold (DIBH) (both strategies are currently being used at our centre). To perform accurate heart-sparing treatments, it is important to ensure that patients are positioned consistently. One available approach is through surface imaging which tracks the position of a portion of the skin surface, known as the AlignRT system (VisionRT Ltd, London, UK).

Conditions

Left-Sided Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Reproducibility of ABC or vDIBH set-up as measured by Align RT.

  Reproducibility of set-up will be evaluated by determining discrepancies in patient's surface between treatment and CT simulation which will be acquired with the Align RT system using multiple measures along with daily portal images during treatment and weekly CBCTs.

  2 years

• Mean heart dose as determined using Align RT.

  Estimate the change in mean heart dose for each breath-hold/heart sparing strategy by: i. Converting differences in heart position on 2D portal images acquired during treatment to 3D volumes on Pinnacle plans. ii. Using the CBCT images (acquired weekly), to recalculate dose to heart based on the patient's position and anatomy that day.

  2 years

Secondary Outcomes (1)

• The impact of Align RT with vDIBH as compared to vDIBH without AlignRT on quality of life as assessed by the EORTC core QoL questionnaire.

  2 years

Study Arms (2)

Active Breathing Control

OTHER

To review our institutional clinical experience of applying the AlignRT system to monitor patient setup and reproducibility when using ABC and DIBH techniques in the treatment of left-sided breast cancer patients.

Device: AlignRT system (VisionRT Ltd., London, UK)

Deep Inspiration Breath Hold

OTHER

To review our institutional clinical experience of applying the AlignRT system to monitor patient setup and reproducibility when using ABC and DIBH techniques in the treatment of left-sided breast cancer patients.

Device: AlignRT system (VisionRT Ltd., London, UK)

Interventions

AlignRT system (VisionRT Ltd., London, UK) DEVICE

To review our institutional clinical experience of applying the AlignRT system to monitor patient setup and reproducibility when using ABC and DIBH techniques in the treatment of left-sided breast cancer patients.

Active Breathing Control; Deep Inspiration Breath Hold

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with diagnosis of left-sided breast malignancy
• Women who require left chest wall or breast irradiation status post mastectomy or lumpectomy
• Treatment with modified wide tangents to include IMCs
• Treatment with four-field technique
• Age \>18 years
• Performance status ECOG \<3
• Patient must be able to maintain a 30 second breath hold
• Conventional chest wall or breast radiation delivery dose of 50Gy/25 or hypofractionated chest wall/breast radiation delivery dose of 42.56Gy/16 with or without a boost

You may not qualify if:

• Right sided breast cancer patients
• Treatment with partial breast irradiation
• Previous left breast/chest wall irradiation
• Locally advanced breast cancer
• Pregnant patients
• Unable to follow commands

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Unilateral Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: March 9, 2018
• Study Start: May 19, 2018
• Primary Completion: December 31, 2021
• Study Completion: January 30, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)